Cardiac Trigger Monitor

Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

Ivy Biomedical Systems, Inc.

The following data is part of a premarket notification filed by Ivy Biomedical Systems, Inc. with the FDA for Cardiac Trigger Monitor.

Pre-market Notification Details

Device IDK202138
510k NumberK202138
Device Name:Cardiac Trigger Monitor
ClassificationMonitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Applicant Ivy Biomedical Systems, Inc. 11 Business Park Drive Branford,  CT  06405
ContactAlejandra Aceves
CorrespondentAlejandra Aceves
Ivy Biomedical Systems, Inc. 11 Business Park Drive Branford,  CT  06405
Product CodeDRT  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-31
Decision Date2021-05-14

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